Digital Follow-Up and Nursing Education in Bariatric Surgery Patients (DigiBarQoL)

March 3, 2026 updated by: Seda Akkaya, Okan University

The Effect of the Use of a PHP-MySQL Database-Based Follow-Up System and Nursing Education on Quality of Life in Patients Undergoing Bariatric Surgery

This randomized controlled experimental study aims to evaluate the effect of a PHP-MySQL database-based digital follow-up system combined with structured nursing education on quality of life, body mass index (BMI), and exercise habits in patients undergoing bariatric surgery. Although bariatric surgery is an effective treatment for morbid obesity, long-term success depends largely on adherence to lifestyle modifications, including regular physical activity and sustained behavioral change.

Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive structured nursing education along with an 8-week digitally monitored exercise program starting at postoperative month four. The control group will receive standard postoperative care. Outcomes will be assessed using the Moorehead-Ardelt Quality of Life Questionnaire II (MA-II), BMI measurements, and the International Physical Activity Questionnaire (IPAQ). The study aims to provide evidence for integrating digital health technologies and structured nursing interventions into postoperative bariatric care.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Obesity is a chronic, multifactorial disease associated with increased morbidity, mortality, and reduced quality of life. Bariatric surgery is considered the most effective long-term treatment for morbid obesity; however, sustainable outcomes depend on adherence to postoperative lifestyle modifications, including regular physical activity, nutritional regulation, and behavioral adaptation. Despite the effectiveness of surgery in achieving initial weight loss, some patients experience insufficient weight reduction or weight regain due to poor adherence to recommended lifestyle changes.

Digital health technologies have emerged as promising tools for improving patient monitoring, self-management, and behavioral compliance. Mobile and web-based follow-up systems may enhance communication between patients and healthcare professionals, facilitate structured exercise adherence, and promote sustained behavioral change. Additionally, structured nursing education plays a critical role in empowering patients, increasing health literacy, and improving postoperative adaptation.

This randomized controlled trial aims to evaluate the effectiveness of a PHP-MySQL database-based digital follow-up system combined with structured nursing education in patients undergoing bariatric surgery. Eligible participants will be randomly assigned to intervention and control groups using a simple randomization method. The intervention group will receive structured nursing education and participate in an 8-week digitally monitored exercise program beginning at postoperative month four. The control group will receive standard postoperative care without structured digital follow-up.

Primary outcome measures include changes in quality of life assessed by the Moorehead-Ardelt Quality of Life Questionnaire II (MA-II). Secondary outcomes include changes in body mass index (BMI), physical activity levels measured by the International Physical Activity Questionnaire (IPAQ), and exercise adherence rates recorded through the digital platform.

The findings of this study are expected to contribute to the development of evidence-based postoperative follow-up models integrating digital health systems and nursing-led behavioral interventions in bariatric care.

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18-65 years Undergoing bariatric surgery Eligible for physical activity participation according to the International Physical Activity Questionnaire (IPAQ) Able to use the PHP-MySQL based digital follow-up system Willing to participate and provide written informed consent

Exclusion Criteria:

  • Severe cardiopulmonary disease or any medical condition that contraindicates exercise Uncontrolled hypertension or uncontrolled diabetes Severe musculoskeletal limitations preventing participation in the exercise program Severe psychiatric disorder impairing compliance or follow-up Participation in another interventional study during the study period Refusal or inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nursing Education and Digital Exercise Follow-Up
Participants will receive structured nursing education and an 8-week structured exercise program beginning at postoperative month four. Exercise sessions will be performed at least three times per week for approximately 40 minutes per session, including warm-up and cooling phases. Adherence and activity records will be monitored through a secure PHP-MySQL based digital follow-up system.
Behavioral: Structured Nursing Education and Exercise Program
Participants will receive structured nursing education supported by an evidence-based educational brochure and will participate in an 8-week structured exercise program starting at postoperative month four. The program will include stretching, aerobic exercise, and cooling phases, performed at least three times per week for approximately 40 minutes per session.
No Intervention: Standart Postoperative Care
Participants will receive routine postoperative follow-up and standard care without additional structured nursing education or digital exercise monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Qality of Life
Time Frame: Baseline and 8 weeks (postoperative month 4 to month 6)
Change in Moorehead-Ardelt Quality of Life Questionnaire II (MA-II) total score from baseline to post-intervention.
Baseline and 8 weeks (postoperative month 4 to month 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okan University

Collaborators

Health Sciences University Istanbul Haydarpaşa Numune Training and Research Hospital

Investigators

  • Principal Investigator: SEDA AKKAYA, MSc, Okan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 7, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OKANU-SBÜ-SA-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly available due to privacy and ethical restrictions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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